LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency; Trophic Ulcers
• Interventions: Device: LASMIK; Other: Conventional therapy

• Registration Number: NCT03104985
• Lead Sponsor: Research Center Matrix

Brief Summary

The aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of C6 class, and a new combined low level laser therapy (LLLT) by LASMIK device.

The results of outpatient examination and treatment of patients with venous trophic ulcers, observed in the City Polyclinic of "Tula Municipal Clinical Hospital №2" were analyzed.

Detailed Description

During a longitudinal study, a group of patients was followed up in the period of complete or partial recovery. International classification of lower extremity chronic venous disorders СЕАР was used as a clinical classification of chronic venous insufficiency (CVI).

Depending on the applied treatment method, patients were divided into 2 groups:

1. (n=34) Conventional treatment

2. (n=34) Conventional treatment + combined LLLT, including external exposure with 635nm wavelength + intravenous laser blood illumination (ILBI) with 365-405nm (UV-spectrum) and 520-525nm (green spectrum) wavelength alternately, according to the special scheme

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-07
• Results First Submitted: 2017-04-17
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Results First Posted: 2018-11-01
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• over 18 years of age,
• CVI Stage 6 (S6) in compliance with СЕАР

Exclusion Criteria

• hemorrhagic syndrome,
• neoplastic syndrome,
• hyperthermic syndrome (fever, patient body temperature over 38°C),
• syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multiple organ failure (general severe illness),
• cachexic syndrome (severe general exhaustion),
• epileptic syndrome,
• hysterical syndrome,
• convulsive syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy and combined LLLT	Conventional therapy	Conventional therapy and combined LLLT (LASMIK device) was performed. External exposure was conducted on the 1-4 affected area during one session for 2 minutes per zone in pulsed mode, light pulse duration - 100-130ns, wavelength - 635nm, by a matrix emitter consisting of eight laser diodes with a surface area of 8cm2, at a distance of up to 7cm, with pulsed power of 40W. ILBI was conducted in continuous mode with wavelength between 365-405nm (UV-spectrum) and 520-525nm (green spectrum) alternately, during 12 daily treatment sessions according to the scheme: 1. - 365-405nm, power 1-2mW, exposure 2 min; 2. - 520-525nm, 1-2mW, 5 min; 3. - 365-405nm, 1-2mW, 2 min; 4. - 520-525nm, 1-2mW, 5 min; 5. - 365-405nm, 1-2mW, 2 min; 6. - 520-525nm, 1-2mW, 5 min; 7. - 365-405nm, 1-2mW, 2 min; 8. - 520-525nm, 1-2mW, 5 min; 9. - 365-405nm, 1-2mW, 2 min; 10. - 520-525nm, 1-2mW, 5 min; 11. - 365-405nm, 1-2mW, 2 min; 12. - 520-525nm, 1-2mW, 5 min
Conventional treatment	Conventional therapy	Conventional treatment only. * An elastic compression of lower extremities: elastic bandages or compression hosiery of class 2 * Pharmacotherapy: Anavenol, Aescusan, Glyvenol; drugs of the Benzopyrone group, including Troxevasin and Venoruton. Trental, Aspirin and Ticlid (Ticlopidine). Nonsteroidal anti-inflammatory drugs (Nimesil, OKI), various ointments containing Heparin, corticosteroids, as well as nonsteroidal anti-inflammatory drugs. Antibiotic therapy. * Topical treatment: in the presence of purulent discharge (phase I of the wound healing process) - bandaging with antiseptic solutions (1% Iodopiron solution, 0.1% Chlorhexidine solution) and hydrophilic ointments (Levosin, Levomecol). In phases II and III - after ulcer cleansing the preparations based on Hyaluronic acid (Curiozin).
Conventional therapy and combined LLLT	LASMIK	Conventional therapy and combined LLLT (LASMIK device) was performed. External exposure was conducted on the 1-4 affected area during one session for 2 minutes per zone in pulsed mode, light pulse duration - 100-130ns, wavelength - 635nm, by a matrix emitter consisting of eight laser diodes with a surface area of 8cm2, at a distance of up to 7cm, with pulsed power of 40W. ILBI was conducted in continuous mode with wavelength between 365-405nm (UV-spectrum) and 520-525nm (green spectrum) alternately, during 12 daily treatment sessions according to the scheme: 1. - 365-405nm, power 1-2mW, exposure 2 min; 2. - 520-525nm, 1-2mW, 5 min; 3. - 365-405nm, 1-2mW, 2 min; 4. - 520-525nm, 1-2mW, 5 min; 5. - 365-405nm, 1-2mW, 2 min; 6. - 520-525nm, 1-2mW, 5 min; 7. - 365-405nm, 1-2mW, 2 min; 8. - 520-525nm, 1-2mW, 5 min; 9. - 365-405nm, 1-2mW, 2 min; 10. - 520-525nm, 1-2mW, 5 min; 11. - 365-405nm, 1-2mW, 2 min; 12. - 520-525nm, 1-2mW, 5 min

Primary Outcome Measures

Name	Time	Method
Number of Participants With Trophic Ulcer Healing	6 months follow up	Number of participants with ulcer epithelialization was counted in both groups. Trophic ulcer healing in 6 months occurred in larger number of participants of conventional therapy and combined LLLT group.

Trial Locations

Locations (1)

Tula Municipal Clinical Hospital №2; 🇷🇺 Tula, Russian Federation